Events

Recall of Device Recall Laser Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beijing Syntech Laser Co., Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79697
  • Event Risk Class
    Class 2
  • Event Number
    Z-1488-2018
  • Event Initiated Date
    2017-07-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163045
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • Reason
    The noncompliance is that the certification label was not affixed on the product, with statement "complies with 21 cfr 1040.10 and 1040.11 except for deviations pursuant to laser notice no. 50, dated june 24, 2007".
  • Action
    Beijing Syntech Laser measures to be taken: 1. Beijing Syntech Laser Co. Ltd. has sent notifications to all relevant dealers, distributors, and purchasers, 2. Beijing Syntech Laser Co. Ltd. will send certification labels and instructions to apply the label to the product to all relevant dealers, distributors, and purchasers, 3. The corrections will be conducted at no cost to the purchaser, and 4.The corrective action will be completed by August 1st, 2018. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22, if it hasnt been already. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call (360) 325-7028

Device

Device Recall Laser Handpiece

Manufacturer

Beijing Syntech Laser Co., Ltd
  • Manufacturer Address
    Beijing Syntech Laser Co., Ltd, International Industry Base, West Area F/4; No. 8 Liye Road; Changping, Beijing China
  • Manufacturer Parent Company (2017)
    Beijing Syntech Laser Co. Ltd.
  • Source
    USFDA